Aurobindo Pharma has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market divalproex sodium extended-release tablets USP 250 mg and 500 mg. (ANDA 202419). The product is ready for launch.
Divalproex sodium extended-release tablets USP 250mg and 500mg is the generic equivalent of AbbVie’s Depakote ER extended-release tablets, 250mg and 500mg respectively and is indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features The product has a market size of approximately $690 million for the twelve months ending March 2014 according to IMS.
The Abbreviated New Drug Application (ANDAs) has been approved out of Unit VII (SEZ) formulation facility in Hyderabad. Aurobindo now has a total of 194 ANDA approvals (168 Final approvals including seven from Aurolife Pharma and 26 tentative approvals) from the US FDA.
EP News Bureau– Mumbai
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